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Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients

NCT00303641 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-28

No results posted yet for this study

Summary

The purpose of this study is to determine if the Medtronic Resting Heart Bypass system is safer and results in less inflammatory reaction than traditional bypass machines used in coronary artery bypass surgery. We hypothesize that the new Medtronic Resting Heart System is safer and results in much less systemic inflammatory reaction in comparison to the standard cardiopulmonary bypass systems currently in use.

Conditions

  • Coronary Artery Bypass Surgery
  • Cardiopulmonary Bypass

Interventions

DEVICE

Medtronic Resting Heart Bypass System

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Bob Kiaii, MD, FRCSC · Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-11-30
Completion
2006-02-28

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303641 on ClinicalTrials.gov